拖把和抹布的清洁规程

一．目的Objective

规范拖把、抹布的清洁程序，防止交叉污染。

Standardize the cleaning procedure of mops and rags and avoid cross-contamination. 二．适用范围Scope

生产区所用的拖把、抹布的清洁、消毒和日常管理。

Apply to the cleaning, disinfection and daily management of the mops and rags in the production area. 三．责任者Responsibilities

操作人员、卫生员：按照本规程实施拖把、抹布的清洁、消毒或灭菌。

The operator, the sanitation man: responsible for the implementation of mops and rags

cleaning and disinfecting in accordance with this procedure.

班长、IPC：按照本规程对拖把、抹布的清洁和消毒效果进行检查。

The monitor, IPC: responsible for checking the cleaning and disinfection effect in accordance with this procedure.

四．相关定义Definition

无。No content.

五．工作程序Procedure

1. 一般原则

General principle

1.1. 洁净区内拖把、抹布应使用无脱落物、易清洗、易消毒或灭菌的材料。

The material of the mops and rags should be no exfoliation ，easily cleaned, easily

disinfected or sterilized.

1.2. 拖把、抹布用后应在规定的清洁间内及时清洗，每次消毒、灭菌后填写《车间拖把、抹布消毒/ 灭菌记录10080》。

The mops and rags should be cleaned and disinfected in their respective cleaning rooms immediately after used. And

workshop10080> should be timely filled.

1.3. 不同洁净级别区域的拖把、抹布不得混用。针对不同用途的抹布需根据颜色进行

区分使用，并在洁具架上标明用途，分类挂放。

Mops and rags in clean areas with different cleaning level should not be intermixed. The different use of rags should be distinguished between according to the different colors, and marked the uses on the sanitary appliance shelf, hung them according to their categories.

1.4. 抹布使用要求

Operating requirements of the rags

1.4.1. 用于擦拭与产品直接接触部位的抹布要专用，并与擦拭其它部位的抹布要分开

洗涤、消毒或灭菌、存放和使用。

The rags which directly contact with the product should be exclusively used, and separated from the rags used in wiping other parts to clean, disinfection or sterilization, store and use.

1.4.

2. 抹布需定期进行更换，C、D 级洁净区抹布三个月或出现明显破损时进行更换，

A/B 级洁净区抹布三个月或灭菌90 次时进行更换，同时在《车间拖把、抹布消毒

/灭菌记录10080》备注中进行记录。

Change the rags every three months or which is broken in C, D clean area, and every three months or which is sterilized up to 90 times in A/B clean area. When change the rags should be noted in .

1.5. 拖把使用要求

Operating requirements of the mops

1.5.1. 拖把应进行编号管理，编号方式为“使用区域-两位数的流水号”，使用区域有：

一般区（简称YBQ）、（D或C或A/B ）级洁净区（简称D或 C 或A/BJJQ）。

具体形式如：YBQ-01 、DJJQ-01、CJJQ-01、A/BJJQ-01。

Number the mops by “used range-double digit serial number”and used range contains

general area（abbreviated to YBQ） and D, C, A/B clean area（abbreviated to D, C,

A/BJJQ）, such as YBQ-01,DJJQ-01,CJJQ-01,A/BJJQ-01.

1.5.

2. 拖把柄上用标签打印机打印并张贴该拖把的用途，形式为“用途：*** ”，具体用途可根据实际使用区域进行简短描述。

Print labels by “usage:*** ” which is described simply according to used range, and paste it to the mopstick.

1.5.3. 拖把在清洁时，若该区域有双桶式榨水车，可先用榨水车对拖把进行初洗，然后

再用“ 2.洗涤方法”中的方法进行彻底清洗。

Clean the mops by the mop wringer with double bucket first when there is a mop wringer with double bucket in the area, and then clean the mops by “2. cleaning methods ” thoroughly.

1.5.4. 清洁、消毒后的拖把应头朝下悬挂在指定洁具架上，洁具架下方应当有集水槽收

集水滴，集水槽应定期进行清洁（一般区为7 天，洁净区为3天）。

Hang the mops on the frames in their own storage room of cleaning tools and collect water by the tank. The tank should be cleaned regularly（7days in general area and 3 days in clean area）.

1.5.5. 拖把（指拖把头）需定期进行更换，C、D 级洁净区拖把三个月或出现明显破损

时进行更换、A/B 级洁净区拖把三个月或灭菌90 次时进行更换，同时在《车间

拖把、抹布消毒/灭菌记录10080》备注中进行记录。

Change the mops every three months or which is broken in C, D clean area, and every three months or which is sterilized up to 90 times in A/B clean area. When change the rags should be noted in . 1.6.清洁剂和消毒剂的使用要求参见《清洁剂和消毒剂使用规程1-00016》。

The use requirement of detergent and disinfectant see the“ SOP for Using Detergent and Disinfectant 1-00016”.

2. 洗涤方法Cleaning methods

2.1. 一般区General area

2.1.1. 拖把、抹布使用后先用饮用水加清洁剂洗涤，再用饮用水冲洗至冲洗水澄清、挤

干。

The mops and rags should be washed first in drinking water with detergents, rinse them in just drinking water to the flush water clear, and then squeeze the water.

2.1.2. 拖把、抹布每周用消毒剂浸泡消毒一次，每次半小时，再用饮用水冲洗至冲洗水

澄清、最后挤干。

The mops and rags should be disinfected once a wee，k and dip them in the disinfector for half an hour every time, rinse them in just drinking water to the flush water clea，r and then squeeze the water.

2.1.

3. 洗涤后的拖把悬挂于指定洁具存放间的存放架上、抹布搭在挂钩上自然晾干。Hang the mops and rags on the frames in their own storage room of cleaning tools, and dry them in the open air just after cleaning.

2.2. 三十万级、十万级、D级洁净区( 2010版GMP)

Three hundred thousand, one hundred thousand grade and D clean area (the 2010 version of the GMP)

2.2.1. 拖把、抹布用后先用纯化水冲洗，再加清洁剂洗涤，最后用纯化水冲洗至冲洗水

澄清、挤干。

The mops and rags should be washed first in purified water with detergent, rinse them in purified water to the flush water clear, and then squeeze the water.

2.2.2. 拖把、抹布每周用消毒剂浸泡消毒一次，每次半小时。再用纯化水冲洗至冲洗水

澄清、挤干。

The mops and rags should be disinfected once a wee，k and dip them in the disinfector for half an hour every time, rinse them in purified water to the flush water clear ，and then squeeze the water.

2.2.

3. 洗涤后的拖把、抹布悬挂于指定洁具存放间的存放架上、抹布搭在挂钩上自然晾

干或烘干。

Hang the mops and rags on the frames in their own storage room of cleaning tools after cleaning, and dry them in the open air or by drier.

2.3. C级洁净区( 2010版GMP)

C grade clean area (the 2010 version of the GMP)

2.3.1. 拖把、抹布使用后先用纯化水加清洁剂擦洗，再用纯化水冲洗至冲洗水澄清、挤

干。

The mops and rags should be washed first in purified water with detergent, rinse them in purified water to the flush water clear, and then squeeze the water.

2.3.2. 拖把、抹布每周用消毒剂浸泡消毒一次，每次半小时。再用纯化水冲洗至冲洗水

澄清、挤干。

The mops and rags should be disinfected once a week, and dip them in the disinfector for half an hour every time, rinse them in purified water to the flush water clear ，and then squeeze the water.

2.3.3. 洗涤后的拖把、抹布悬挂于本区域洁具存放间的存放架上，抹布挂在挂钩上自然

晾干或采用适宜的设备进行干燥。

Hang the mops and rags on the frames in their own storage room of cleaning tools after cleaning. Dry them in the open air or by appropriate equipment.

2.4. A/B 级洁净区( 2010 版GMP)

A/B grade clean area (the 2010 version of the GMP)

2.4.1. 拖把、抹布使用后，经无菌区与低级别洁净区的传递窗传递至相应辅助区域进行

清洗。

After used, the mops and rags are cleaned in the corresponding secondary zone to which

passed by the transfer window between sterile area and clean area of the low-level.

2.4.2. 将拖把、抹布先用纯化水加清洁剂洗涤，再用纯化水冲洗至冲洗水澄清，最后

用注射用水冲洗一遍，挤干，存放于洁具存放架上。

Firstly, washing the mops and rags with purified water adding detergent, and then rinse them with purified water to rinse water clarification, and finally washed again with the water for injection, squeezed, stored on the frames.

2.4.

3. 拖把、抹布使

用前应灭菌：将拖把、抹布放于呼吸袋中送入灭菌柜，按设定的灭菌程序进行灭菌并干燥(织物程序，根据灭菌设备不同可设定为：121℃灭菌

20min，干燥20min 或121℃灭菌30min，干燥30min)，将灭菌后的拖把、抹布放于层流罩下备用。

Before using, the rags should be cleaned, dried and sterilized: the rag will be put into the sterilizer by the breath bag in the specified container, and should be sterilized and dried in the sterilization procedures set (fabric program can be set according to the sterilization equipment as follows: 121 C ste°rilization for 20min, drying 20min, or 121 C sterilization° for 30min and drying 30min). After sterilization, the rag is put in the laminar flow hood for spare.

3. 清洁后存放期限

Time limit for storage after cleaning

3.1. 一般区拖把、抹布清洁后存放时间不超过一周。

In the common area, for the mops and rag，s the time limit should be less than a week after cleaning.

3.2. 三十万级、十万级、C/D 级区( 2010版GMP)拖把、抹布清洁后存放时间不超过

72h。

In three hundred thousand, one hundred thousand, and C/D grade (2010 GMP), for the mops and rags，the time limit should be less than 72h after cleaned.

3.3. A/B 级区(2010版GMP)拖把、抹布灭菌后存放时间原则上不应超过8h或经验证

的有效存放时间。

A/B Grade (2010 version of the GMP), in principle, the rags storage time after sterilization, should be less than 8h or effective storage time proven.

3.4. 超过上述规定时间，应重新进行清洁、消毒或灭菌。

If it is more than the allotted time, it should be re-cleaned, disinfected or sterilized.

4. 双桶式榨水车使用要求

The use requirement of the mop wringer with double bucket

4.1. 在两个桶( A 桶、B 桶)中放入适量相应区域使用的工艺用水(一般区为饮用水，洁净

区为纯化水)，将拖把先放入 A 桶内浸湿，然后榨干，污水流入 A 桶；再将拖把放入 B 桶浸湿，再榨干，污水流入 A 桶，拖把可开始拖地。

Put the required amount of process water of corresponding regions used (the general area for drinking water, clean area for purified water) into the two buckets (A bucket, B bucket), and put the mop into the A bucket to soak first, then dry it and make the sewage flow into the A bucket. Then put the mop into the B bucket to soak, and dry it, make the sewage flow into the A bucket, then the mop can be used.

4.2. 拖把使用后需要清洗时先放入 A 桶中浸泡清洗，榨干后污水流入 A 桶，然后将拖把

放入 B 桶浸泡清洗再榨干，污水流入 A 桶，拖把可再次开始拖地。

The mop should be put into the A bucket to soak and clean if it is necessary after using, then dried to make the sewage flow into the A bucket. After that, put the mop into the B bucket to soak and clean, then dry it to make the sewage flow into the A bucket. Then the

mop can be used again.

4.3. 两个桶中的工艺用水影响清洁效果时需及时更换。

The process water in the two buckets should be changed timely if it impact the cleaning

effect.

4.4. 双桶式榨水车使用后清洁方法

The cleaning method of the mop wringer with double bucket after using —用工艺用水将两个桶内外表面冲洗至无可见污迹(必要时用抹布进行擦拭清洁) 。

The internal and external surfaces of the two buckets should be rinsed to no visible stains by process water (wipe and clean with a rag if necessary) —用抹布将车身表面擦拭至无可见污迹。

Wipe the body surface of the mop wringer with a rag to no visible stains. —用蘸有消毒剂的抹布擦拭双桶内外表面及车身进行消毒。

Use the rag which moistened with the disinfectant to wipe the internal and external surfaces of the two buckets and the body surfaces of the mop wringer. —清洁榨水车用的抹布需单独使用。

The rag used in cleaning mop wringer should be used separately.

4.5. 一般区使用的双桶式榨水车每次使用后及时清洁，每周消毒一次。洁净区使用的

双桶式榨水车每次使用后及时清洁、消毒。

The mop wringers with double bucket used in general area should be cleaned timely after each use, and disinfected once a week. The mop wringers used in clean area should be cleaned and disinfected timely after each use.

5. 各使用部门可根据本SOP 中的规定及各部门的具体情况修订详细的管理规定。

Make the detailed management regulation according to the SOP and concrete conditions of the departments.

六．制定依据Basis

本文件制定依据为《药品生产质量管理规范( 2010 年修订)》。

This document is established according to (GMP2010).

七. 相关文件和记录Related Documents and Records

1.相关文件Related Documents

2.相关记录Related Records

八．附录Appendix

1.双桶式榨水车Mop Wringer with Double Bucket

B 桶 B Bucket

A 桶 A Bucket 九．变更记载Change Record